Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors

Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor

This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVES:

I. Examine associations between social support, strain, and isolation and phenotypic aging over the 1-year recovery period.

II. Examine associations between social support, strain, and isolation and biological aging over the 1-year recovery period.

III. Test biological aging as a mediator linking social processes and phenotypic aging.

EXPLORATORY OBJECTIVE:

I. Test sex differences in Aims 1 and 2.

OUTLINE:

Adopting a prospective design, participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives16. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome-wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital and the Medical College of Wisconsin
      • Contact: Kelly Rentscher, PhD; Phone Number: 414-955-8990; Email: krentscher@mcw.edu
      • Principal Investigator: Kelly Rentscher, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing HCT for hematologic cancers.

Description

Inclusion Criteria:

• Aged 18 years and older who are competent to give their informed consent.
• Ability to read, speak, and understand English.
• Received a hematopoietic cell transplant within the previous 100 days.

Exclusion Criteria:

• Less then Aged 18 years and older who are competent to give their informed consent.
• Cannot read, speak, and understand English.
• Has not received a hematopoietic cell transplant within the previous 100 days.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Supportive care (EAR, questionnaires, biospecimen collection); Participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates.

Other: Questionnaire Administration; Complete questionnaires; Procedure: Biospecimen Collection; Undergo collection of blood sample; Other: Electronic Health Record Review; Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations between social support, strain, and isolation and phenotypic aging	Multiple regression models will examine subjective and objective measures of each social process as separate predictors of change in phenotypic aging over the 1-year period, accounting for covariates.	through study completion, an average of 1 year
Associations between social support, strain, and isolation and biological aging	Raw gene expression data will be quantile-normalized and log2-transformed. Similar to Aim 1, multiple regression models will examine each social process as separate predictors of change in cellular senescence marker p16INK4a over the 1-year period, accounting for covariates. Mixed linear models will examine associations between each social process and deoxyribonucleic acid damage response (DDR) and senescence-associated secretory phenotype (SASP) gene profiles, estimated by maximum likelihood to account for systematic differences across genes by treating them as repeated measurements with an unstructured covariance matrix. Bioinformatics analyses will use regression models to identify genes with > 1.5-fold difference.	through study completion, an average of 1 year
Biological aging as a mediator linking social processes and phenotypic aging	A regression-based mediation approach will examine biological aging (p16INK4a messenger ribonucleic acid, DDR and SASP composites) as mediating variables in associations between each social process and change in phenotypic aging, using the PROCESS macro for SPSS statistical software.	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex differences	Multiple regression models will examine interactions between social support, strain, and isolation and biological sex as separate predictors of biological (Aim 1) and change in phenotypic (Aim 2) aging, accounting for covariates.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kelly Rentscher, PhD, Medical College Of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 43000 (Other Identifier: Medical College of Wisconsin); NCI-2021-02616 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); K01AG065485 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No